MAUDE Adverse Event Report: VOLCANO CORPORATION VOLCANO VERRATA PRESSURE GUIDE WIRE; WIRE, GUIDE, CATHETER

Catalog Number 10185

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/26/2016

Event Type  malfunction  

Event Description

We had a pressure wire that failed to work when connected."fractional flow reserve (ffr) wire failed to ever connect to ffr system for measurement." we just dropped a new pressure wire on the field, and everything else went fine.

• Brand Name: VOLCANO VERRATA PRESSURE GUIDE WIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore rd.; rancho cordova CA 95670
• MDR Report Key: 5719769
• MDR Text Key: 47203750
• Report Number: 5719769
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 10185
• Other Device ID Number: (01)00845225002435
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/31/2016
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/13/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 65